Therapeutic Goods (Charges) Amendment Act 2018

Overview

The Therapeutic Goods (Charges) Amendment Act 2018, enacted by the Parliament of Australia, serves to modify the Therapeutic Goods (Charges) Act 1989. This legislative amendment addresses the need to introduce charges for conformity assessment body determinations, which are essential for ensuring the safety and efficacy of therapeutic goods. The Act aims to streamline the regulatory framework for therapeutic goods by aligning it with the Therapeutic Goods Act 1989 and addressing gaps in the financial management of conformity assessments. The policy objective is to enhance the oversight and regulation of therapeutic goods by ensuring that the appropriate fees are charged for the assessments of conformity, thereby supporting the overall integrity of the therapeutic goods market in Australia.

Scope and Application

The Therapeutic Goods (Charges) Amendment Act 2018 amends the Therapeutic Goods (Charges) Act 1989, with the primary objective of modifying the charges associated with therapeutic goods, including those related to conformity assessment body determinations. This Act applies to all conformity assessment bodies that are required to be determined by the Therapeutic Goods Administration under the Therapeutic Goods Act 1989. The geographic and jurisdictional reach of this Act is at the Commonwealth level, applying across Australia. The amendments made by this Act are intended to affect the financial year in which this item commences and each subsequent financial year. Subordinate instruments may extend or restrict the application of this Act further, although the primary Act itself does not specify any exclusions, exemptions, or thresholds explicitly. The commencement of the Act is divided into two parts, with sections 1 to 3 and any unspecified provisions commencing upon receiving Royal Assent on 5 March 2018, and Schedule 1, which includes the amendments, commencing on 6 March 2018, contingent on the commencement of Schedule 5 to the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018.

Key Provisions

The Therapeutic Goods (Charges) Amendment Act 2018 introduces several amendments to the Therapeutic Goods (Charges) Act 1989, primarily concerning the imposition and payment of charges for conformity assessment body determinations. Under section 1 of Schedule 1, the title of the 1989 Act is altered to include the making of conformity assessment body determinations. Additionally, section 3(1) is amended to incorporate the interpretation provisions of the Therapeutic Goods Act 1989, ensuring consistency in the interpretation of terms such as the registration of therapeutic goods, including provisional registration of medicines. An annual charge is introduced for conformity assessment body determinations in force during a financial year (Schedule 1, item 4). This charge is payable for each conformity assessment body determination, regardless of the number of goods or classes of goods covered by the determination (Schedule 1, item 5). The amendments also clarify that when goods are included in the provisionally registered goods part of the Register due to section 6AAE of the Therapeutic Goods Act 1989, the provisions of the 1989 Act apply as if the goods had been registered under Part 3-2 of that Act (Schedule 1, item 6). Furthermore, the scope of section 5(2) is expanded to include conformity assessment body determinations of different kinds (Schedule 1, item 7). The application provision in Schedule 1 ensures that these amendments apply from the financial year in which the Act commences and to each subsequent financial year. The Therapeutic Goods (Charges) Amendment Act 2018 imposes several obligations on entities subject to the charges for conformity assessment body determinations. Firstly, entities must ensure that an annual charge is paid for each conformity assessment body determination in force during a financial year. This charge is to be calculated and paid in accordance with the prescribed amount set out in the regulations made under the Act. Secondly, entities must adhere to the interpretation provisions of the Therapeutic Goods Act 1989, particularly concerning the registration of therapeutic goods, including provisional registration of medicines. This requires entities to correctly classify and report the status of their goods as per the Act's provisions. Additionally, entities must be aware of the implications when goods are included in the provisionally registered goods part of the Register due to section 6AAE of the Therapeutic Goods Act 1989. In such cases, entities must treat these goods as if they had been registered under Part 3-2 of the 1989 Act. Finally, entities must consider the expanded scope of section 5(2) to include conformity assessment body determinations of different kinds. The Therapeutic Goods (Charges) Amendment Act 2018 does not explicitly outline specific offences, penalties, or civil/criminal consequences for breach within the text provided. However, it is reasonable to infer that breaches of the requirements to pay annual charges for conformity assessment body determinations or to correctly classify and report the status of therapeutic goods could lead to enforcement actions under the Therapeutic Goods Act 1989 or other relevant legislation. Such actions might include fines, compliance orders, or other administrative penalties as prescribed by law. The specific penalties would depend on the nature and severity of the breach, as well as any additional provisions set out in the regulations made under the Act.